清痰化瘀方对稳定性冠心病患者血管内皮功能影响的随机对照研究

Effect of Qingtan Huayu Formula on Vascular Endothelial Function in Patients with Stable Coronary Heart Disease:A Randomized Controlled Trial

目的运用血浆一氧化氮(NO)、内皮素-1(ET-1)及肱动脉血流介导的血管舒张功能(FMD),多维度同步评价清痰化瘀方对稳定性冠心病患者血管内皮功能的影响。方法采用随机、对照、单盲研究方法。将60例稳定性冠心病痰热瘀结证患者随机分为治疗组和对照组,每组30例。对照组按原西药治疗方案不变,治疗组在原西药治疗方案基础上加用清痰化瘀方,疗程为(10±3)天。检测两组患者NO、ET-1、FMD、血脂(TG、TC、LDL-C、HDL-C、VLDL-C)水平及心外膜脂肪组织(EAT)厚度,并进行安全性评价。结果研究中2例患者被剔除,最终纳入58例,其中治疗组29例,对照组29例。与本组治疗前比较,治疗后治疗组血清NO水平及FMD值升高(P<0.01),ET-1水平及EAT厚度下降(P<0.01,P<0.05),对照组ET-1水平升高(P<0.05);与对照组同期比较,治疗组治疗后血浆NO水平及FMD值升高(P<0.01,P<0.05),ET-1水平降低(P<0.01),EAT差异无统计学意义(P>0.05)。两组患者治疗前后血压、心率、血常规、电解质、尿常规未见明显变化;肝、肾功能,不良事件发生率比较,差异无统计学意义(P>0.05)。结论清痰化瘀方能改善稳定性冠心病痰热瘀结证患者血管内皮功能,且安全性良好。

Objective To simultaneously evaluate the effect of the Qingtan Huayu Formula(QTHYF)on vascular endothelial function in stable coronary heart disease patients using plasma nitric oxide(NO),endothelin-1(ET-1)and brachial artery flow-mediated dilation(FMD).Methods A randomized,controlled,single-blind trial was performed.Sixty stable coronary heart disease patients with phlegm heat and blood stasis syndrome were randomly assigned to the treatment group and the control group,30 cases in each group.All patients received conventional Western medicine treatment,while those in the treatment group additionally took QTHYF,the therapeutic course for all was(10±3)days.The levels of NO,ET-1,FMD,blood lipids(including TG,TC,LDL-C,HDL-C,and VLDL-C)and epicardial adipose tissue(EAT)thickness were detected in the two groups,and the safety was evaluated.Results Two patients were excluded,and 58 patients were finally included,29 in each group.Compared with before treatment in the same group,serum NO level and FMD values increased(P<0.01),and ET-1 level and EAT thickness decreased(P<0.01,P<0.05)in the treatment group after treatment,while the level of ET-1 increased in the control group(P<0.05).Compared with the control group,NO level and FMD values increased(P<0.01,P<0.05),and ET-1 level decreased(P<0.01)after treatment in the treatment group,while there was no significant difference in EAT(P>0.05).There was no significant changes in blood pressure,heart rate,blood routine,electrolytes,and urine routine between the two groups before and after treatment,and there was no significant difference in liver and kidney function and incidence of adverse events(P>0.05).Conclusion QTHYF could improve the vascular endothelial function in stable coronary heart disease patients with phlegm heat and blood stasis syndrome,and it has good safety.